Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study

Not Applicable

Not yet recruiting

• Conditions: Malnutrition (Calorie); Stem Cell Transplant Complications

• Registration Number: NCT07010068
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary

prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-19
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Intact intestinal tract
• Life expectancy more than 12 weeks
• Allogeneic stem cell transplantation
• Signed informed consent

Exclusion Criteria

• Active hematological disease at the beginning of conditioning
• Personal history of inflammatory bowel diseases
• Personal history of bowel resection
• Personal history of gastric bypass procedures
• Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome)
• Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevention	given from day -7 to day +28	● PG-SGA score C (severe malnutrition) at day +28 \<50%